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Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction:a Retrospective Matched Case-control Study

Primary Purpose

Heart Failure With Reduced Ejection Fraction, Thoracic Epidural Anesthesia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TEA plus GDMT
GDMT
Sponsored by
First Affiliated Hospital of Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The present study was a retrospective, observational, matched case-control study of 1,840 consecutive inpatients, in New York Heart Association functional class II-IV with a left ventricular ejection fraction (LVEF) ≤40%, who were hospitalized from July 2013 to August 2019. Exclusion Criteria: Patients were excluded because of insufficient patient information, refusal to participate, or loss to follow-up by telephone. In patients with multiple hospitalizations during the time period, the first hospitalization was utilized in the analysis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    GDMT plus TEA

    GDMT

    Arm Description

    The patients received maximally tolerated guideline-directed medical therapy (GDMT) plus TEA. Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures.

    The patients received maximally tolerated GDMT.

    Outcomes

    Primary Outcome Measures

    heart failure mortality in the patients with HFrEF
    heart failure mortality in the patients with HFrEF

    Secondary Outcome Measures

    heart failure rehospitalization in the patients with HFrEF
    heart failure rehospitalization in the patients with HFrEF

    Full Information

    First Posted
    September 28, 2023
    Last Updated
    September 28, 2023
    Sponsor
    First Affiliated Hospital of Harbin Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06068166
    Brief Title
    Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction:a Retrospective Matched Case-control Study
    Official Title
    Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction:a Retrospective Matched Case-control Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2013 (Actual)
    Primary Completion Date
    August 31, 2019 (Actual)
    Study Completion Date
    August 31, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Affiliated Hospital of Harbin Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Despite significant scientific breakthrough in management, patients with heart failure with reduced ejection fraction (HFrEF) remain high morbidity and mortality, with a 5-year survival rate of 25% after hospitalization for HFrEF. The autonomic nervous system (ANS), particularly the sympathetic nervous system (SNS), plays a critical compensatory role in maintaining cardiovascular homeostasis in the failing heart. This is critical given the huge unmet need for novel treatment strategies for HFrEF. Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures. Since 1995, Professor Liu Fengqi has pioneered the use of TEA to treat end-stage HFrEF and achieved surprising results. TEA could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. Currently, thousands of HFrEF patients have received TEA procedure. However, it is unclear whether TEA could positively impact the clinical outcomes of patients with HFrEF.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure With Reduced Ejection Fraction, Thoracic Epidural Anesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1840 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GDMT plus TEA
    Arm Type
    Experimental
    Arm Description
    The patients received maximally tolerated guideline-directed medical therapy (GDMT) plus TEA. Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures.
    Arm Title
    GDMT
    Arm Type
    Active Comparator
    Arm Description
    The patients received maximally tolerated GDMT.
    Intervention Type
    Combination Product
    Intervention Name(s)
    TEA plus GDMT
    Intervention Description
    Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures. Since 1995, Professor Liu Fengqi has pioneered the use of TEA to treat end-stage HFrEF and achieved surprising results. TEA could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. Currently, thousands of HFrEF patients have received TEA procedure. All the patients received maximally tolerated guideline-directed medical therapy (GDMT).
    Intervention Type
    Drug
    Intervention Name(s)
    GDMT
    Intervention Description
    All the patients received maximally tolerated guideline-directed medical therapy (GDMT) alone.
    Primary Outcome Measure Information:
    Title
    heart failure mortality in the patients with HFrEF
    Description
    heart failure mortality in the patients with HFrEF
    Time Frame
    8.5 years
    Secondary Outcome Measure Information:
    Title
    heart failure rehospitalization in the patients with HFrEF
    Description
    heart failure rehospitalization in the patients with HFrEF
    Time Frame
    8.5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The present study was a retrospective, observational, matched case-control study of 1,840 consecutive inpatients, in New York Heart Association functional class II-IV with a left ventricular ejection fraction (LVEF) ≤40%, who were hospitalized from July 2013 to August 2019. Exclusion Criteria: Patients were excluded because of insufficient patient information, refusal to participate, or loss to follow-up by telephone. In patients with multiple hospitalizations during the time period, the first hospitalization was utilized in the analysis.

    12. IPD Sharing Statement

    Learn more about this trial

    Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction:a Retrospective Matched Case-control Study

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